# K100312: Distalock Femoral Intramedullary Nail System

- Pathway: 510(k) (Special)
- Applicant: Dgimed Ortho, Inc.
- Decided: Apr 20, 2010 after 75 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K893377 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091309: Revolution Femoral Intramedullary Nail System, Model Dgooxx, Dgimed Ortho, Inc. (2009) Summary page 1.

## Indications for use
The DISTALOCK Femoral Intramedullary Nail System is indicated for use in orthopedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.

Source page: https://510kreport.com/device/K100312
Methodology: https://510kreport.com/methodology